This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

Average number of clinical events over 12 months post-treatment. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.

A secondary objective will be to evaluate the changes from baseline to 12 months post-treatment in the distance walked as measured by the 6-minute walk test.

Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

A secondary objective will be to evaluate the change in left ventricular function as measured by echocardiography for left ventricular ejection fraction (LVEF).

Change from baseline to 12 months post-treatment in quality of life. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

A secondary objective will be to evaluate the change in quality of life (total score) in patients treated with ixmyelocel-T compared to placebo using the Minnesota Living with Heart Failure Questionnaire.

A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM from time of aspiration through 12 months post-treatment/follow-up by % of patients with adverse events.

12-20 transendocardial NOGA® -guided injections of 0.4 mL of vehicle control per injection into the left ventricle.

Detailed Description:

The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

Eligibility

Ages Eligible for Study:

30 Years to 86 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and non-pregnant, non-lactating females;

Age 30 to 86 years of age;

Diagnosis of ischemic dilated cardiomyopathy;

LVEF ≤ 35% by echocardiogram;

Symptomatic heart failure in NYHA functional class III or IV;

Subject is not a candidate for reasonable revascularization procedures that will produce clinical improvement;

Subject is receiving appropriate clinical standard of care heart failure therapy, as tolerated and as dictated by a subject's current medical condition, for at least 30 days prior to screening;

Must have an automatic implantable cardioverter defibrillator (AICD);

Worsening heart failure hospitalization or equivalent within 6 months prior to screening, hospitalization equivalent defined as an unplanned outpatient/emergency department visit for treatment of acute decompensated heart failure; or have an N-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥2000 pg/mL or BNP ≥400 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤400 meters at screening;

Life expectancy of at least 12 months in the opinion of the Investigator;

Given medical history and concurrent medication, subject is an acceptable candidate for bone marrow aspiration and cardiac catheterization and transendocardial injection procedures in the opinion of the Investigator;

Willing and able to comply scheduled visits and tolerate study procedures.

Diabetic subjects with uncontrolled or untreated proliferative retinopathy as determined by dilated eye exam administered by a qualified eye care professional as per American Diabetes Association guidelines;

Chronic exposure to cytotoxic therapy for oncologic or chronic non-oncologic reasons in the prior 3 months or expected requirement over the course of the study;

Concurrent participation in another interventional clinical trial or receiving experimental intervention within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product or previously received allogeneic cell therapy, autologous cell therapy cultured with animal proteins.

In the opinion of the Investigator, the subject is unsuitable for cellular therapy or has a food/drug allergy, surgical or medical condition, clinically significant psychiatric disorders, poor nutritional status, or lab abnormality requiring further medical evaluation that may interfere with the investigational product, interfere with the study results' interpretation, interfere with the subject's ability to complete the study or compromise the subject's safety.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01670981